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DEMONSTRATED
SAFETY PROFILE1

LEQVIO® was well tolerated
over 18 months

Most common adverse reactions in
≥3% of patients treated
with
LEQVIO and more frequently than
placebo1

Most common adverse reactions with LEQVIO

ªIncludes related terms such as injection site pain, erythema, and rash.

2.5% of patients discontinued LEQVIO vs 1.9% with placebo1

The safety profile of LEQVIO was consistent across all subgroups, including elderly, hepatic, and renally impaired patient populations1*

*LEQVIO was not studied in patients with end-stage
renal disease or severe hepatic impairment.

Injection site reactions were the most
common causes for treatment
discontinuation (0.2% of patients taking
LEQVIO vs 0% taking placebo).1

  • All were localized, predominantly mild,
    or occasionally moderate4

THERE'S MORE TO KNOW ABOUT LEQVIO

Effective and sustained
LDL-C reduction is
possible for your patients1†

STUDY CLINICAL DATA arrow

†Greater LDL-C reducation was maintained
during each 6-month dosing interval vs
placebo as a complement to a maximally
tolerated statin.

INDICATION AND IMPORTANT
SAFETY INFORMATION

COLLAPSE

EXPAND

INDICATION

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

Limitations of Use: The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.

IMPORTANT SAFETY INFORMATION

Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO and more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea.

Adverse reactions led to discontinuation in 2.5% and 1.9% of LEQVIO- and placebo-treated patients, respectively. Discontinuation due to injection site reactions, which included injection site pain, erythema and rash, were 0.2% and 0% of LEQVIO- and placebo-treated patients, respectively.

Please click here for LEQVIO full Prescribing Information.

References: 1. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 2. Cubanski J, Damico A, Neuman T, Jacobson G. Sources of supplemental coverage among Medicare beneficiaries in 2016. KFF. November 28, 2018. Accessed November 5, 2021. https://www.kff.org/medicare/issue-brief/sources-of-supplemental-coverage-among-medicare-beneficiaries-in-2016/# 3. Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in patients at high cardiovascular risk with elevated LDL cholesterol. N Engl J Med. 2017;376(15):1430-1440. doi:10.1056/NEJMoa1615758 4. Data on file. Novartis Pharmaceuticals Corp; 2019. 5. Grundy SM, Stone NJ, Bailey AL, et al. AHN/AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625 6. Data on file. Novartis Pharmaceuticals Corp; 2020. 7. Ray KK, Wright RS, Kallend D, et al; ORION-10 and ORION-11 Investigators. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 8. McClellan M, Brown N, Califf RM, Warner JJ. Call to action: urgent challenges in cardiovascular disease: a presidential advisory from the American Heart Association. Circulation. 2019;139(9):e1-e11. doi:10.1161/CIR.0000000000000652 9. Jacobson T, Cheeley MK, Jones PH, et al. The STatin Adverse Treatment Experience Survey: experience of patients reporting side effects of statin therapy. J Clin Lipidol. 2019;13(6):405-424. 10. Jones PH, Radhika N, Thakker KM. Prevalence of dyslipidemia and lipid goal attainment in statin-treated subjects from 3 data sources: a retrospective analysis. J Am Heart Assoc. 2012;1(6):1-10. doi:10.1161/JAHA.112.001800 11. Fox KM, Tai M-H, Kostev K, Hatz M, Qian Y, Laufs U. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018;107(5):380-388. doi:10.1007/s00392-017-1193-z 12. Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011–2012. J Clin Lipidol. 2016;10(5):1109-1118. doi:10.1016/j.jacl.2016.06.011

INDICATION

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

Limitations of Use: The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.

IMPORTANT SAFETY INFORMATION

Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO and more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea.

Adverse reactions led to discontinuation in 2.5% and 1.9% of LEQVIO- and placebo-treated patients, respectively. Discontinuation due to injection site reactions, which included injection site pain, erythema and rash, were 0.2% and 0% of LEQVIO- placebo-treated patients, respectively.

Please click here for LEQVIO full Prescribing Information.

References: 1. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 2. Cubanski J, Damico A, Neuman T, Jacobson G. Sources of supplemental coverage among Medicare beneficiaries in 2016. KFF. November 28, 2018. Accessed November 5, 2021. https://www.kff.org/medicare/issue-brief/sources-of-supplemental-coverage-among-medicare-beneficiaries-in-2016/# 3. Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in patients at high cardiovascular risk with elevated LDL cholesterol. N Engl J Med. 2017;376(15):1430-1440. doi:10.1056/NEJMoa1615758 4. Data on file. Novartis Pharmaceuticals Corp; 2019. 5. Grundy SM, Stone NJ, Bailey AL, et al. AHN/AHA/ACC/AACVPR/AAPA/ABC/ACPM/
ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625 6. Data on file. Novartis Pharmaceuticals Corp; 2020. 7. Ray KK, Wright RS, Kallend D, et al; ORION-10 and ORION-11 Investigators. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 8. McClellan M, Brown N, Califf RM, Warner JJ. Call to action: urgent challenges in cardiovascular disease: a presidential advisory from the American Heart Association. Circulation. 2019;139(9):e1-e11. doi:10.1161/CIR.0000000000000652 9. Jacobson T, Cheeley MK, Jones PH, et al. The STatin Adverse Treatment Experience Survey: experience of patients reporting side effects of statin therapy. J Clin Lipidol. 2019;13(6):405-424. 10. Jones PH, Radhika N, Thakker KM. Prevalence of dyslipidemia and lipid goal attainment in statin-treated subjects from 3 data sources: a retrospective analysis. J Am Heart Assoc. 2012;1(6):1-10. doi:10.1161/JAHA.112.001800 11. Fox KM, Tai M-H, Kostev K, Hatz M, Qian Y, Laufs U. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018;107(5):380-388. doi:10.1007/s00392-017-1193-z 12. Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011–2012. J Clin Lipidol. 2016;10(5):1109-1118. doi:10.1016/j.jacl.2016.06.011